Endoscope Reprocessing

8/14/2019 Endoscope Reprocessing

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Endoscopy Reprocessing

THETA Education Day


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Endoscope Reprocessing

Device Classification

Manual Cleaning

Personal Protective Equipment

Biofilms within GI Endoscopy

Reprocessing Room Standards

Endoscope Reprocessing Protocols

Leakage Testing

Endoscope Handling


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Review of Terms

Biofilmrefers to a complex community of microorganisms thatform a matrix of extracellular material composed ofexopolysaccharides (EPS)

Minimum Effective concentration (MEC)refers to the lowestconcentration of active ingredient necessary to meet the label claimof a reusable high-level disinfectant / sterilantchemical teststrips should be used to determine whether and effectiveconcentration of the active ingredient is present despite repeated

use

Reuse-liferefers to a statement by the manufacturer indicatingthe maximum number of days of a reusable high-level disinfectant/ sterilant might be effective


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Two classifications of Endoscopes

Critical Endoscope:

Endoscopes used in the examination of critical spaces such as jointsand sterile cavities. Many of these endoscopes are rigid with nolumen. Examples of critical endoscopes are arthroscopes and

laproscopes

Semicritical Endoscope

Fiberoptic or video endoscopes used in the examination of the hollowviscera. These endoscopes generally invade only semicritical spaces,although some of their components might enter tissue or other critical

spaces ie. Forceps. Examples of semi-critical endoscopes arecolonoscopes, gastroscopes, duodenoscopes, sigmoidoscopes,laryngoscopes, nasopharangeal endoscopes and enteroscopes.

Opininons differ regarding the reprocessing requirements ofbronchoscopes; a minimum of high level disinfection is required


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Medical Device Classification

Spaulding Classification

Determines the degree of disinfection or sterilization required forvarious medical devices.

Critical: A device that enters normally sterile tissue, including thevascular system. These devices should be sterilized

1)Semicritical: A device that comes into contact with intact mucous

membranes and does not ordinarily penetrate sterile tissue. Thesedevices are cleaned followed by High Level Disinfection

2)Noncritical: Devices that do not ordinarily touch the patient ortouch only intact skin. These devices may be cleaned by low-leveldisinfection


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Manual Cleaning

Manual Cleaning

Thorough and meticulous manual cleaning of all instruments mustprecede exposure to any high-level disinfectant or sterilant. Thisprocess significantly reduces the organic and microbial challenge tothe high-level disinfectant or sterilant. An item that has not beencleaned cannot be assuredly disinfected or sterilized.

Refer to endoscope manufacturers guidelines for design featuresunique to a particular instrument


Should be used when reprocessing endoscopes. Gowns, gloves andprotective eyewear are recommended when handling any high-leveldisinfectant / sterilant


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Gownsimpervious to fluid, long sleeves that fit snugly aroundthe wrist, and wrap to cover as much of the body as possible.Dispose of or launder gowns if they become wet or are exposed

to contaminated materialGlovesinspect for tears or holes before use. Gloves should be

long enough to extend up the arm to protect the forearm orclothing from splashes or seepage. To prevent cross-contamination, change gloves and wash hands whenever moving

from a dirty to clean task or environmentEye and / or face protection are necessarycontact lenses are

not sufficient eye protection. A face shield is recommended. Donot use high filtration masks since they may actually trapvapours.


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Biofilms

Biofilms within GI Endoscopy

A biofilmis a structured community of microorganismsencapsulatedwithin a self-developed polymeric matrix and adherent to a living orinert surface.If the colonists are not immediately separated from the surface, theycan anchor themselves more permanently using cell adhesionBiofilms within endoscopy may form within endoscopes if propermanual pre-cleaning and CSGNA guidelines are not followed forendoscope reprocessing

Staphylococcus

aureus biofilm

Exopolysaccharide (EPS)

Staphylococcus aureus
http://en.wikipedia.org/wiki/Microorganismhttp://en.wikipedia.org/wiki/File:Staphylococcus_aureus_biofilm_01.jpghttp://en.wikipedia.org/wiki/Microorganism


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The process and products used for cleaning, disinfection and

or/sterilization of endoscopes must be compatible with theequipment being used

Each health care setting in which endoscopic procedures areperformed should have written detailed procedures for thecleaning and handling of endoscopes

Reprocessing of contaminated patient equipment should bedone in an area designated and dedicated for this function

This room should be separate from where endoscopicprocedures are performed

Ventilation must be capable of removing toxic vapours

generated by, or emitted from, cleaning or disinfectant agentsthe vapour concentration of the chemical disinfectant beingused should not exceed allowable limits (eg. 0.05 ppm forglutaraldehyde)

Minimum of 10-12 air exchanges per hour in the reprocessing

area


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Tap water and / or water that has been filtered by passage througha 0.2micron filter or water of equivalent quality should be availablein the reprocessing area

Manual cleaning should include a medical grade, low-foaming,neutral pH enzymatic formulated for endoscopes that contain

enzymes to digest all components of bioburden; including, blood, fat,carbohydrate, uric acid, starch

Accessories

Accessories which are classified as critical devices (e.g. biopsy

foceps) require sterilization. Critical items labeled for single-useshould not be reprocessed and / or reused.


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Transportation and Handling of

Contaminated Endoscopes

Covered containers with easily cleanable surfaces should beused for handling and transporting soiled endoscopes

Soild endoscopes should be transported by direct routes where

cleaning will be performed

Containers used to transport soiled endoscopes should becleaned after each use


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Basic steps to clean and perform high-leveldisinfection of gastrointestinal endoscopes

1) Pre-cleaning

2) Leakage testing3) Cleaning

4) Rinsing

5) Disinfection

6) Rinsing

7) Drying

8) Storage


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A. Pre-cleaning

1) Immediately after removal of the insertion tube from thepatient and prior to disconnecting the endoscope from thepower source

Prepare for bedside cleaning:

PPE Container with enzymatic Sponge or lint-free cloth Air and water channel cleaning adapters per manufacturers

instruction

Protective video cap

2) Wipe the insertion tube with the wet cloth or sponge soakedin the freshly prepared enzymatic solution. Note that thecloth / sponge should be disposed of between cases


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A. Pre-cleaning

3) Place the distal end of the endoscope into the enzymatic solution.Suction the solution through the biopsy / suction channel, alternatesuctioning enzymatic solution and air several times until thesolution is visibly cleanFinish by suctioning air

Note:Alternate suctioning of fluid and air is more effective thansuctioning fluid alone in the removal of debris from lumens immediate flushing of the biopsy/suction and air/water channelsprecludes drying of debris on lumen surfaces


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A. Pre-cleaning

4) Flush or blow out air and water channels in accordance withthe endoscope manufacturers instructions

5) Flush the auxiliary water channel

6) Detach the endoscope from the light source and suction pump7) Attach protective video cap if using a video endoscope

8) Transport the Endoscope to the reprocessing area in anenclosed container

Note: Containers, sinks, and basins should be large enough thatthe endoscope will not be damaged by being coiled too tightly


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B. Cleaning the Endoscope in the Reprocessing Area

Prepare the following:

PPE Leakage testing equipment Channel cleaning adapters

Large basin of endoscope detergent solution Channel cleaning brushes Sponge or lint-free cloth

C. Leak Testing

Leak Testing detects damage to the interior or exterior of theendoscope

The leak test is done before immersion of the endoscope inreprocessing solutions to minimize damage to parts of theendoscope not designed for fluid exposure.


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C. Leak Testing

1. Manual Leak Testing

Remove suction valves, air water valves, and biopsy valves

Attached the leak tester and pressurize the scope beforesubmerging it in water

With the pressurized insertion tube completely submerged,flex the distal portion of the scope in all directions, observingfor bubbles

Submerge the entire endoscope and, observing the control

head of the scope, depress the freeze and release buttons.

Check the insertion tube and distal bending section as well asthe universal cord for bubbles coming from the interior of thescope


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C. Leak Testing

1. Computerized leak testing Remove suction valves, air water valves, and biopsy valves Attach the leak tester to the computer unit Input data including scope ID and user Move knobs and depress the freeze and release buttons when

indicated Reprocess when test is complete

Follow the endoscope manufacturersinstructions if a leak or high humidity

is detected or if the endoscope appearsdamaged


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Existing Manual Leak Test Methods

Two Methods: Wet Test & Dry Test Both methods should take ~3 minutes

of uninterrupted technician time if done properly

Human Error Factors:

Takes skill, commitment and dedication

Rushing

Leak detection problems

Lack of consistency and/or training

Manual Equipment Error Factors:

No automated detection

100% reliance on visual leak observation

Lack of procedure control

No record keeping

Endoscope Reprocessing Overview


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Fluid Invasion

Pathogen inpatient #1

enters

scope via

leak

Cross-patient

infection

breakout

e.g. Pseudomonas,Salmonella, HIV,

Hepatitis B and C,

Staph, E. coli, C. diff

Leak

harbors

pathogen

from

disinfection

Pathogen

dislodged in

subsequent

procedures

into other

patients

*APICGuideline for

infection

prevention and

control in

flexible

endoscopy

Volume 28,

number 2, p.145


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Endoscope Reprocessing Study Results

1%of endoscopy procedures result in the endoscope

developing a leak

65%of leaks are currently detected (35% undetected) and

undetected leaks lead to fluid invasion

60%of endoscope repair costs are fluid invasion-related

.2%of endoscopy procedures result in fluid invasion

without a leak present (usually due to poor handling

such as cleaning cap left off or poorly sealed)

10-15%of patient-ready endoscopes possess a leak

Endoscope Reprocessing Overview


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D. Cleaning Solutions

Composition of soil found on endoscopes includes, proteins, fats,carbohydrates and the various chemical salts that exist in bloodand other body fluids.

Ideally, a cleaning solution should have a broad spectrum of

effectiveness against these various contaminants and not harmthe device being cleaned

i) Enzymatic cleaning solutions use surfactants to breakdown anddigest bioburden. They are specifically selected to have anegligible effect on surface tension while still suspending soilparticles. This feature provides easy rinsibility.


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E. Cleaning

Manual cleaning of endoscopes is necessary immediatelyafter removing the endoscope from the patient and priorto automated or manual disinfection

Performed as the first and most important step in removing themicrobial burden from an endoscope

Retained debris may inactivate or interfere with the capability ofthe active ingredient of the chemical solution to effectively killand /or inactivate microorganisms


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E. Cleaning

1. Fill a sink with freshly prepared solution of water and a medicalgrade, low-foaming, neutral pH detergent formulated forendoscopesEnzymatic detergent must be discarded after eachuse.

2. Dilute and use according to the detergent manufacturersinstructions.

3. Immerse the endoscope

4. Wash all the debris from the exterior of the endoscope bybrushing and wiping the instrument while submerged in thedetergent solution. Note that the instrument should be leftunder water during the cleaning process to prevent splashing ofcontaminated fluid and aerosolization of bioburden


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E. Cleaning

5. Use a small, soft brush to clean all removable parts, including insideand under the suction valve, air/water valve, and biopsy port cover andopenings.

6. Brush all accessible endoscope channels including the body, insertiontube and the umbilicus of the endoscopebrushes used for cleaninglumens should be of an appropriate size, inspected before and after useand discarded or cleaned, high-level disinfected and dried following use

7. After each passage, rinse the brush in enzymatic solution, removing anyvisible debris before retracting and reinserting it

8. Continue brushing until there is no debris visible on the brush9. Cleanining items should be disposable or thoroughly cleaned and

minimum of high-level disinfected between cases.


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Endoscope Reprocessing ProtocolsE. Cleaning

10. Attach the endoscope cleaning adapters for suction, biopsy, air, andwater channelsNote:Automated pumps are available for this step that eliminate

the manual flush

11. Attach the manufacturers cleaning adapters for special endoscope channels(dual channel, elevator channel, auxilliary channel)

i. To achieve adequate flow through all lumens, various adapters or channelrestrictors may be required

ii. The elevator channel of a duodenoscope is a small lumen, this channelrequires manual reprocessing using a 2-5mm syringe

12. Flush all channels with the detergent solution to remove debris

13. Soak the endoscope and its internal channels for the period of time specifiedby the label

14. If immediate reprocessing is not possible the endoscope shouldbe leak-tested, flushed, brushed, and allowed to soak in aenzymatic solution until it can be thoroughly reprocessed


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F. Rinse After Cleaning

Thoroughly rinse the endoscope and all removable parts withclean water to remove

Purge water from all channels using forced air. Dry the exteriorof the endoscope with a soft, lint-free cloth to prevent dilution of

the liquid chemical germicide used in subsequent stepsG. High Level Disinfection

Recognized as the standard of reprocessing for endoscopes by:

CSGNA / SGNA

CPSOCollege of Surgeons of Ontario ASGEAmerican Society for Gastrointestinal Endoscopy ACG - American College of Gastroenterology AGA - American Gastroenterological Association APIC - Association for Professionals in Infection Control and

Epidemiology

CDCCenters for Disease Control and Prevention


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Automated Endoscope

Reprocessing

Ensure that the endoscope and endoscope components arecompatible with the automated endoscope reprocessor (AER)

Follow the OEM instructions for use in the AER

AER provide a method by which a permanent record ofendoscope use and reprocessing can be monitored andvalidated

Some AER have a system capable of tracking endoscopes andpatients. For each procedure the patients name and recordnumber, the date and time of procedure, type of procedure,the endoscopist and the serial number of the endoscope arerecorded and stored to assist in outbreak investigation.


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Endoscope Reprocessing ProtocolsF. DRYING

Purge all channels with air until dry

Flush all channels, including accessory channels, with alcoholuntil the alcohol until the alcohol can be seen exiting theopposite end of each channel

i. 70% isopropyl alcohol is used to assist in drying the interiorchannel surfaces

ii. Use alcohol that has been properly stored in a closed containerbetween usesalcohol, when exposed to air, rapidly evaporates,and if below the recommended percentage level, cannot berelied upon to assist in the drying process

iii. Alcohol flushes should be used even when sterile water is usedfor rinsing

Purge all channels with air. Alcohol mixes with the remaining water onthe channel surfaces and acts to encourage evaporation of the residualwater as air flows through the channel


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F. DRYING Purge all channels with air. Alcohol mixes with the remaining

water on the channel surfaces and acts to encourageevaporation of the residual water as air flows through thechannel

Remove all channel adapters

Dry the exterior of the endoscope with a soft, clean lint-freetowel

Thoroughly rinse and dry all removable parts. Do not attachremovable parts to the endoscope during storage as this lowersthe risk of trapping liquid inside the instrument


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Endoscope Reprocessing ProtocolsF. DRYING

Drying the endoscope after every reprocessing cycle, bothbetween patient procedures and before storage is a requisitepractice crucial to the prevention of bacterial transmission

Drying is as important to the prevention of diseasetransmission as cleaning and high level disinfection

G. STORAGE

Hang the endoscope vertically, with the distal tip hanging freely in aclean, well-ventilated dust-free area

A storage area with good ventilation will encourage continued air drying

of the surfaces, and prevent undue moisture build-up, thusdiscouraging any microbial contamination

Caps, valves and other detachable components should be removedduring storage and reassembled before use

Colonoscopes have a minimum shelf life of 7 days, if stored dry


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Endoscope Reprocessing

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